(135 days)
HL168KF automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method. All values can be read out in one LCD panel. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for use by people over the age of 18 with wrist circumference ranging from approx. 5.3 to 7.7 inches(13.5 cm to 19.5 cm) and for home use.
When the device detects the appearance of irregular heartbeats during measurement, an indicated symbol will appear with measuring readings. Besides, HL168KF features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth device after measurement.
HL168KF uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate. The measurement position is at human being's wrist. All values can be read out in one LCD panel. The device is designed for home use and recommended for use by adults aged 18 years and older with wrist circumference ranging approx. 5.3 ~ 7.7 inch (13.5 ~ 19.5 cm). The user is able to set the personal target value and the device will flash the value when the measured blood pressure value exceeds the target one. Further, HL168KF features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth device after measurement. Additionally, the device will display a symbol of wor or mo. to indicate the detection of irregular heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat during the measurement.
The Full Automatic (NIBP) Blood Pressure Monitor, Model HL168KF, complies with the ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/A2:2006/(R) 2008 Standard for Manual, electronic, or automated sphygmomanometers.
1. Acceptance Criteria and Reported Device Performance
The provided document states that the device's accuracy for pressure is +/- 3mmHg and for pulse is +/- 5%. These are the stated acceptance criteria, and the document implies the device meets these standards by stating, "All the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pressure Accuracy: +/- 3mmHg | Meets requirements |
| Pulse Accuracy: +/- 5% | Meets requirements |
2. Sample Size for Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only states that "All the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met."
3. Number of Experts and Qualifications for Ground Truth
The document does not provide information on the number of experts used to establish the ground truth for the test set or their specific qualifications.
4. Adjudication Method
The document does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No information regarding an MRMC comparative effectiveness study, or the effect size of AI assistance for human readers, is present in the provided text. The device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool.
6. Standalone Performance (Algorithm Only)
Yes, a standalone performance evaluation was conducted. The device itself is an automated blood pressure monitor that measures systolic and diastolic blood pressure and heart rate using the oscillometric method without human intervention during the measurement process. The clinical tests performed assess the device's direct performance against established standards for sphygmomanometers.
7. Type of Ground Truth Used
The type of ground truth used is implied to be a standard reference measurement as dictated by the ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/A2:2006/(R) 2008 Standard. This standard involves comparison to auscultatory (manual) measurements taken by trained observers, often against a mercury sphygmomanometer, for validation of automated blood pressure devices.
8. Sample Size for Training Set
The document does not specify any training set size or methodology. The device is an oscillometric blood pressure monitor, and its algorithms are typically based on well-established physical principles rather than a machine learning training set in the conventional sense.
9. How Ground Truth for Training Set Was Established
As the device relies on established oscillometric principles rather than a machine learning training set, the concept of establishing ground truth for a training set in the typical AI/ML context is not applicable here. The device's underlying algorithm is designed and validated against the physiological accuracy requirements outlined in the relevant ANSI/AAMI standards.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).